RecruitingPHASE2INTERVENTIONAL

Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

This study is testing a new treatment called TARA-002 for adults with a type of bladder cancer that has not spread into the deeper muscle layer. This type is called high-grade non-muscle invasive bladder cancer. The treatment involves putting a liquid, TARA-002, directly into the bladder. Researchers want to understand how safe TARA-002 is and how well it works to treat this cancer. The study is open to patients who haven't had a previous treatment called BCG, or those who had it a long time ago. It's also for patients whose bladder cancer didn't respond to BCG treatment. The main goal is to gather more information on this new treatment in a group of patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Protara Therapeutics

Enrolment target

131

Start

15 Sep 2023

Estimated completion

01 Mar 2032

Non-muscle Invasive Bladder Cancer

What is this study about?

This study is looking into a new treatment called TARA-002 for a type of bladder cancer. Specifically, it's for adults whose cancer is classified as "high-grade non-muscle invasive bladder cancer". This means the cancer cells look more aggressive under a microscope, but they haven't grown into the muscle layer of the bladder. The current treatment, BCG, works for many people, but not for everyone, and some patients can't have it.

The researchers are giving TARA-002 as a liquid directly into the bladder, which is called an "intravesical instillation". They want to see how safe this treatment is and how well it helps control the cancer. This is a "Phase 2" study, which means they are building on earlier research to get more information about the treatment's effects in a larger group of patients with this specific type of cancer.

The study includes different groups of patients: those who haven't had BCG before, those who had BCG a while ago, and those whose cancer didn't respond to BCG treatment. By studying these different groups, the researchers hope to understand TARA-002's potential as a new option for people living with this bladder cancer.

Key takeaways

This study is for adults with a specific type of bladder cancer that hasn't spread to the muscle.
It's testing a new liquid treatment called TARA-002, given directly into the bladder.
The main goals are to check the treatment's safety and how well it works.
It's open to those new to, or who haven't responded to, standard BCG bladder cancer treatment.
You must be 18 years or older with active high-grade non-muscle invasive bladder cancer to be considered.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. You must have a confirmed diagnosis of high-grade non-muscle invasive bladder cancer, which includes CIS (Carcinoma in Situ) and might also involve stages Ta or T1. This means the cancer is active and was found within three months before you agree to join the study.

The study is looking for two main groups of people. The first group includes those who have never had the standard BCG treatment for their bladder cancer, or those who had BCG at least two years ago. The second group is for people whose bladder cancer didn't respond adequately to previous BCG treatment.

However, some things would mean you can't join. For example, if you have a known allergy to penicillin. Also, if your cancer has spread to your lymph nodes, other organs, or if you've ever had a more advanced type of bladder cancer (stage T2 or higher), you wouldn't be able to participate. They will also check if there's any cancer involvement in your prostate or upper urinary tract.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have high-grade non-muscle invasive bladder cancer (CIS, ± Ta/T1) that is currently active?
Have you either never had BCG treatment, or had it more than 2 years ago, or your cancer didn't respond to BCG?
Have you *never* had a more advanced bladder cancer (stage T2 or higher)?
Do you *not* have a penicillin allergy?

Answer every question to see your result.

What does participation involve?

The information provided is a brief summary, and doesn't detail what participating in the study would fully involve. Typically, taking part in a clinical trial involves a series of hospital or clinic visits where you would receive the study medication (TARA-002 as a liquid put into your bladder). You would have regular check-ups, which might include scans, urine tests, and bladder examinations to see how the treatment is working and to monitor for any side effects. The total length of your participation, how often you'd need to visit, and the specifics of the follow-up care would be fully explained by the study team. You would receive detailed instructions on how the TARA-002 is given and what to expect at each stage.

Potential risks and benefits

Participating in a study like this might offer a potential benefit of trying a new treatment for your bladder cancer that isn't widely available yet. This treatment could potentially help manage your cancer. However, as with any new medicine, there are potential risks, and TARA-002 may cause side effects that are not yet fully known. These side effects could range from mild to serious. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (66)

Urology Centers of Alabama
Verified postcode
Homewood, United States· Recruiting
Mayo Clinic
Verified postcode
Phoenix, United States· Recruiting
East Valley Urology Center of Arizona
Verified postcode
Queen Creek, United States· Recruiting
Arkansas Urology
Verified postcode
Little Rock, United States· Recruiting
Michael Oefelein Clinical Trials
Verified postcode
Bakersfield, United States· Recruiting
Urology Group of Southern California
Verified postcode
Los Angeles, United States· Terminated
University of California Irvine Medical Center
Verified postcode
Orange, United States· Recruiting
Genesis Research
Verified postcode
San Diego, United States· Withdrawn
Genesis Research LLC
Verified postcode
Torrance, United States· Recruiting
Colorado University - Anshutz
Verified postcode
Aurora, United States· Recruiting
AdventHealth Medical Group Urology of Denver
Verified postcode
Denver, United States· Recruiting
Advanced Urology
Verified postcode
Lakewood, United States· Recruiting

Common questions

What is 'non-muscle invasive bladder cancer'?

This is a type of bladder cancer where the cancer cells are only in the lining of the bladder and haven't grown into the deeper muscle layer.

What does 'intravesical instillation' mean?

It means the treatment liquid, TARA-002, is put directly into the bladder through a thin tube called a catheter.

What is 'BCG unresponsive'?

This means that the previous standard treatment for bladder cancer, called BCG, didn't work well or stopped working for your cancer.

What is a 'Phase 2 study'?

A Phase 2 study is when a new treatment has shown promise in earlier tests, and now researchers are looking more closely at its safety and how well it works in a larger group of people with the condition.

Will I get TARA-002 if I join the study?

Yes, all participants in this particular study will receive the TARA-002 treatment.

How to find out more

Chief Scientific Operations Officer

clinicaltrials@protaratx.com 16468440337 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.